Primary research question:Will the use of Aquacel Ag Surgical as a postoperative wound dressing result in less postoperative wound infections?
ID
Source
Brief title
Condition
- Skin and subcutaneous tissue disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The hypothesis is that Aquacel Ag Surgical will result in a lower rate of
postoperative wound infections because of the silver coating.
Secondary outcome
none
Background summary
Breast cancer has a high incidence among women. Almost every woman diagnosed
with breast cancer should undergo surgery (breast ablative surgery or breast
conserving surgery).
There is no consensus about the best choice for wound dressing after breast
cancer surgery.
Aquacel Ag Surgical is a fluid absorbing material with a silver coating. The
absorption of wound exsudate will result in a dry woud with no need for
frequent renewal of the wound dressing. The silvercoating should result in less
postoperative wound infections.
Aquacel Ag Surgical is mainly used as a wound dressing in orthopedic surgery.
In orthopedic surgery Aquacel Ag Surgical has proven to reduce postoperative
wound infections.
The hypothesis is that Aquacel Ag Surgical will reduce postoperative wound
infections because of the silver coating.
Study objective
Primary research question:
Will the use of Aquacel Ag Surgical as a postoperative wound dressing result in
less postoperative wound infections?
Study design
Randomized Controlled Trial, non blinded.
Patients will be randomized in two groups: standard wound dressing or Aquacel
Ag Surgical
Stratification is performed for the following criteria:
• Age (younger than 60 years versus 60 years and older)
• Axillary node dissection (yes / no)
• Diabetes (yes / no)
• Use of corticosteroids (yes / no)
• Operation (lumpectomy versus ablation)
Intervention
The use of Aquacel Ag Surgical instead of a gauze and tape
Study burden and risks
The risks are nihil (possible allergies for the wound dressing)
Kleiweg 500
Rotterdam 3045PM
NL
Kleiweg 500
Rotterdam 3045PM
NL
Listed location countries
Age
Inclusion criteria
Women diagnosed with breast cancer who will undergo breast surgery (ablative therapy or breast conserving therapy)
Exclusion criteria
-local inflammation or ulceration of the breast
-use of antibiotics 2 weeks prior to surgery
-prior breast surgery past 3 months
-allergy for Aquacel Ag Surgical
-the inability of reading/understanding not enabling to give informed consent or to fill out questionnaires
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL42892.101.12 |
| OMON | NL-OMON24162 |